MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068503000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Stenosis (2263); Discomfort (2330); Prolapse (2475); Hematuria (2558); Dyspareunia (4505)
Date of Event	11/28/2006
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling system device was implanted into the patient during a lynx sling procedure performed on (b)(6) 2006, for the treatment of stress urinary incontinence.Physical exam revealed marked bladder neck hypermobility with leakage, with repetitive coughing.Patient noted that she developed dysuria just prior to menstrual period and following sexual activity.On (b)(6) 2021, the patient underwent lynx sling removal, urethral lysis, anterior colporrhaphy, abdominal paravaginal and removal of abdominal mesh due to vaginal pain, pelvic pain, chronic urinary tract infections, pain with coitus, urinary stricture and infected sling.This was a very difficult surgery due to the urethral scarring and infected sling.The previous lynx sling was identified to be infected with a foul smell.The mesh was incised in the midline and dissected the left and right free.A urethral lysis was performed with sharp dissection to further free the urethra and scar tissue on the left and on the right.The sling on the left and right were freed from the underlying tissues and bladder wall and dissected laterally into the retropubic space as far as possible.The entire lynx sling was removed.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.
Additional Manufacturer Narrative
Block b3 date of event: date of event was approximated to (b)(6) 2006, implant date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The explant surgeon is: dr.(b)(6).(b)(6) clinic tower.Block h6: the following imdrf patient codes capture the reportable events of: e2330: pain, e1310: infection, urinary tract, e1405: dyspareunia - pain with coitus, e2337: stenosis, non-vascular - urinary stricture, e1906: infection, e1715: scar tissue (cicatrix), e2311: discomfort, e1302: hematuria.The following imdrf impact codes capture the reportable events of: f1903: device explantation - entire sling was removed, f1901: additional surgery - urethral lysis.

• Brand Name: LYNX SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17547484
• Report Number: 3005099803-2023-04238
• Device Sequence Number: 20567713
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female